血管内碎石术治疗外周动脉钙化:破坏性 PAD III 观察性研究的 30 天结果。

IF 1.7 2区 医学 Q3 PERIPHERAL VASCULAR DISEASE
Ehrin J Armstrong, George Adams, Peter A Soukas, Sarang S Mangalmurti, Nicolas W Shammas, Anderson Mehrle, Barry Bertolet, William A Gray, Gunnar Tepe, Edward Y Woo, James F McKinsey, Andrew Holden, Sahil A Parikh
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引用次数: 0

摘要

目的:在大型试验和小型真实世界经验中,血管内碎石术(IVL)对钙化性外周动脉疾病(PAD)显示出良好的安全性和有效性。目前还缺乏来自更大群体的真实世界证据,因此我们旨在评估 IVL 治疗钙化 PAD 的真实世界急性期表现:Disrupt PAD III 观察性研究(OS)是一项前瞻性、多中心、单臂研究。跛行或危及肢体缺血(CLTI)且至少有中度钙化的患者均符合条件。通过多变量分析评估了手术结果的独立预测因素:2017年11月至2021年6月期间,全球30个地点的1373名患者共登记了1677个病变(1531个,91.3%的核心实验室可评估)。直径狭窄率和病变长度分别为80.6±17.6%和93.5±74.3毫米。靶血管包括股骨干动脉(61%)、髂动脉(15.8%)、股总动脉(10.7%)和膝下动脉(12.8%)。病变特征包括31.1%的慢性全闭塞(CTO)和19.3%的长病变(≥15厘米)。最终评估结果显示,残余狭窄率为(23.8±11.3)%,严重血管造影并发症为0.9%,无突然闭塞、远端栓塞、无血流或血栓事件。残余狭窄≤30%的独立预测因素是病变长度≥15厘米(比值比[OR]=0.384)、女性(OR=1.850)、年龄≤75岁(OR=1.625)、IVL球囊与动脉比值≥1.0(OR=1.538)和CTO病变(OR=0.638)。病变长度≥15厘米(OR=16.076)是手术并发症的独立预测因素:Disrupt PAD III OS是对钙化PAD IVL围手术期疗效的最大规模评估。结论:Disrupt PAD III OS 是对钙化性 PAD IVL 围手术期结果的最大规模评估,证实了在多个外周血管床的复杂病变中具有极佳的手术安全性和有效性:临床影响:PAD III OS 的最终分析是日常临床实践中使用外周 IVL 的最大规模报告。这项研究的结果表明,之前在临床试验中报告的程序结果可以应用到更广泛的患者群体中。在严重钙化的下肢狭窄病变中使用外周静脉输液治疗显示出一致的急性安全性和狭窄缩小效果,即使是跨多个血管床的复杂患者也是如此。此外,多变量分析还证实了适当的IVL球囊尺寸对实现出色的急性狭窄缩小效果的重要性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Disrupt PAD III Observational Study.

Purpose: Intravascular lithotripsy (IVL) has shown promising safety and effectiveness in calcified peripheral artery disease (PAD) in large trials and small real-world experiences. Real-world evidence from a larger cohort is lacking, so we aimed to evaluate the real-world acute performance of IVL in the treatment of calcified PAD.

Materials and methods: The Disrupt PAD III Observational Study (OS) is a prospective, multicenter, single-arm study. Patients with claudication or critical limb-threatening ischemia (CLTI) and at least moderate calcification were eligible. Independent predictors of procedural outcomes were assessed by multivariable analysis.

Results: Between November 2017 and June 2021 across 30 global sites, 1373 patients with 1677 lesions (1531, 91.3% core lab evaluable) were enrolled. Diameter stenosis and lesion length was 80.6±17.6% and 93.5±74.3 mm, respectively. Target vessels included femoropopliteal (61%), iliac (15.8%), common femoral (10.7%), and infrapopliteal arteries (12.8%). Lesion characteristics included 31.1% chronic total occlusions (CTOs) and 19.3% long lesions (≥15 cm). At final assessment, residual stenosis was 23.8±11.3%, with 0.9% serious angiographic complications, no abrupt closures, distal embolization, no flow, or thrombotic events. Independent predictors of ≤30% residual stenosis were lesion length ≥15 cm (odds ratio [OR]=0.384), female sex (OR=1.850), age ≤75 years (OR=1.625), IVL balloon to artery ratio ≥1.0 (OR=1.538), and CTO lesions (OR=0.638). Lesion length ≥15 cm (OR=16.076) was an independent predictor of procedural complications.

Conclusions: The Disrupt PAD III OS represents the largest assessment of IVL periprocedural outcomes in calcified PAD. It confirmed excellent procedural safety and effectiveness in complex lesions across multiple peripheral vascular beds.

Clinical impact: This final analysis of the PAD III OS represents the largest report of peripheral IVL utilization in daily clinical practice. The outcomes of this study indicate that previously reported procedural results in clinical trial settings can be translated to a broader patient population. Treatment with peripheral IVL in severely calcified stenotic lower limb lesions demonstrated consistent acute safety and stenosis reduction, even in complex patients across multiple vessel beds. In addition, the importance of proper IVL balloon sizing to achieve excellent acute stenosis reduction was confirmed by multivariate analysis.

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来源期刊
CiteScore
5.30
自引率
15.40%
发文量
203
审稿时长
6-12 weeks
期刊介绍: The Journal of Endovascular Therapy (formerly the Journal of Endovascular Surgery) was established in 1994 as a forum for all physicians, scientists, and allied healthcare professionals who are engaged or interested in peripheral endovascular techniques and technology. An official publication of the International Society of Endovascular Specialists (ISEVS), the Journal of Endovascular Therapy publishes peer-reviewed articles of interest to clinicians and researchers in the field of peripheral endovascular interventions.
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